唑来膦酸与替勃龙对绝经后骨质疏松症骨密度、骨代谢指标及骨折影响的临床研究  

Effects of zoledronic acid and tibolone on bone mineral density, indexes of bone metabolism, and the risk of fracture in patients with postmenopausal osteoporosis

作　　者：宣森[1] 杨军[1] 李颖[1] 周筠[1] 王博[1] 宋利格[1] 王永兰[1] 张秀珍[1] 

机构地区：[1]同济大学附属同济医院内分泌代谢研究室,上海200065

出　　处：《中华内分泌代谢杂志》2013年第6期504-508,共5页Chinese Journal of Endocrinology and Metabolism

基　　金：国家自然基金项目（30872726）

摘　　要：目的比较唑来瞵酸与替勃龙治疗绝经后骨质疏松症患者骨密度、骨代谢指标的变化及其对骨折发牛的影响。方法选择年龄55～60岁的PMOP共567例，全部患者均服用钙尔奇D600mg／d．骨化二醇0．25μg／d，随机分为唑来膦酸组（A），唑来膦酸5mg／年，静脉注射（n=185）；替勃龙组（B），替勃龙2．5mg／d，口服（／2=190）；对照组（C），单纯服用钙尔奇D600mg／d，骨化三醇0．25μg／d（n=192）。各组均于用药前和用药后6、12、24个月分别用放免法测定骨特异性碱性磷酸酶（BALP）、抗酒石酸酸性磷酸酶5b（tartrate—resistantacidphosphatase，TRACP-5b）；定量夹心酶联免疫法测定骨钙素、I型胶原C末端肽（collagentypeIC—endpeptides，CTX），同时进行骨密度测定，胸、腰椎正侧位X线检查及脆性骨折发生情况评估等，并进行统计分析。结果与C组相比，A组和B组腰柞24个月L2_4骨密度提高6．07％（P〈0．001）和4．28％（P=0．003），股骨颈骨密度提高3．59％（P=0．023）和3．24％（P=0．042）。A、B组间比较，A组高于B组，但差异无统计学意义。A组和B组BALP、骨钙素、TRACP-5b、CTX水平治疗后24个月较治疗前均下降（P〈0．01）；A、B两组间比较BALP、骨钙素差异无统计学意义（P〉0．05）；TRACP-5b、CTX有碌著性差异（P〈O．01）。与C组相比A组新发椎体骨折率下降61．9％（P=0．033），髋部为0。总的骨折下降65．9％（P=0．004）；B组总的新发骨折发生卒下降48．4％（P=0．047）。各组均未发现严重不良事件。结论治疗PMOP唑来膦酸与替勃龙两者均疗效显著，具有升高骨密度及有效地降低骨折发生的作用，而唑来膦酸疗效与替勃龙相似，同时唑来膦酸提高了患者依从性和安全性；单纯服用钙剂和维生素D不能有效地治疗PMOP．Objective An open study was carried out to evaluate the effect of 2 year of zoledronic acid and tibolone treatment on bone mineral density （BMD） , bone remodeling markers, and the risk of fracture in women with postmenopausal osteoporosis（PMOP）. Methods In total, 567 PMOP women, whose ages ranged 55-64 years, were randomized to 3 groups. 185 patients received infusion zoledronic aeid 5 mg/year, 190 patients received oral tibolone 2.5 mg/d and the rest received oral cahrate and calcitriol （ control group, n = 192 ）. All of them received oral cahrate 600 mg/d and cah：itriol 0.25 μg/day. BMD measurements at the lmnbar spine and femoral neck by dual-energy X-ray ahsorptiometry （DEXA） and the biochemical markers of bone metabolism in serum were performed at the baseline and 6, 12, and 24 months. Results Comparing baseline with 24 month＇s values, BMD increased in zoledronic acid and tibohme group, especially lumbar vertebra （ L2-4, P 〈 0. 01 ）. But there was no significant deference between zoledronic acid and tibolone group （P 〉 0. 05 ）. Zoledronic acid and tibolone resulted in a significantly greater reduction in bone-specific alkaline phosphatase （BALP） , osteocalcin, tartrate-resistant acid phosphatase （TRACP- 5b） , and collagen type I C-end peptides （CTX）fi＇om baseline all post-baseline time （P〈 0. 01 ）. There was a significant deference between zoledronic acid and tibolone group in TRACP-5b and CTX（ P〈0.05 ）. Treatment with zoledronic acid reduced the risk of new vertebral fracture by 61.9% during a 2-year period, as compared with placebo （4.3% in the zoledronie-acid group vs 12.6% in the control group, P = 0. 033 ）and reduced the risk of total fracture by 65.9% （4.3% in the zoledronic-acid group, 12.6% in the control group, P = 0. 004）. And in Tibolone group, incidence of total fraeture were, significantly lower than in the control group（6.5% vs 12.6% , P=0. 047 ）. Therewas no serious adverse event occurrence in all patientsm. Conclusions Zol

关 键 词：唑来膦酸 替勃龙 骨密度 骨折 

分 类 号：R681[医药卫生—骨科学]